We are disappointed with the delay in the US Food and Drug Administration’s (FDA) approval for Johnson and Johnson’s (JNJ) drug carisbamate. The new drug application (NDA) filed in October last year was seeking approval for carisbamate for the treatment (along with other medicines) of partial onset of seizures for patients aged 16 years and above.

The FDA sent a complete response letter (CRL) to the company indicating that the agency needs more time and information before approving the drug. J&J has not yet disclosed the detailed contents of the CRL. The company is currently evaluating the letter and will respond to the agency as soon as possible.

According to IMS Health, the global market for anti-epileptic drugs in 2008 was $16.9 billion. With carisbamate, J&J was seeking to regain the lost sales due to genericization of Topamax, which was one of the company’s top-selling drugs (Topamax recorded $2.7 billion of sales in 2008 sales). The other top-selling anti-epileptic drugs include GlaxoSmithKline’s (GSK) Lamictal (sales of £926 million in 2008), Pfizer’s (PFE) Lyrica ($2.57 billion sales in 2008), and Novartis’ (NVS) Tegretol and Trileptal among others.

Unfortunately, with the delay in FDA approval, J&J will suffer as Topamax is experiencing generic competition (the US patent expired in September 2008 and pediatric exclusivity expiring in March 2009). For the first half of the year, J&J recorded $784 million in Topamax sales, a huge decline of 41% from the year-ago period. For the second quarter alone, sales of Topamax were $182 million, a decline of 73% from the same period last year. The second quarter depicts the true picture of the scenario as J&J had pediatric exclusivity for the drug until March 2009.

We expect the trend of declining sales to continue in the coming quarters as well due to intensifying generic competition. With J&J hoping to regain lost sales of Topamax by converting patients to carisbamate, the delay in the product’s approval is a major setback for the company.
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